FDA.reportPublic FDA data

Emtricitabine and Tenofovir Disoproxil Fumarate

Product NDC
42385-953
11-digit product format
423850953
Labeler code
42385
Product ID
42385-953_bf69c830-aa6f-4813-8421-6b3bd689086d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Emtricitabine and Tenofovir Disoproxil Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Laurus Labs Limited
Application
ANDA212114
Marketing category
ANDA
Marketing start
2019-07-26
Substance
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength
200; 300 mg/1; mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Emtricitabine and Tenofovir Disoproxil Fumarate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMTRICITABINE200 mg/1
TENOFOVIR DISOPROXIL FUMARATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG70B4ETF4S, OTT9J7900I
Rxcui476556

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33cd1557-9629-1a35-1f2f-499cf7c608bcProduct name220260305
5f93de8c-a439-4aaa-862f-7cf2524cb240Product name320250812
6286e356-28a5-4b4b-a174-76bf53b211e3Product name620250121
233e3f87-da6c-4b7d-80cb-963ca3258270Product name220240419
dc21b1c2-b0f7-7f56-b95f-dcd93cbc30a4Product name320240320
c0c98dbe-5e23-74e9-f9fc-07af05f77d95Product name820240319
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
1cd1fd33-94db-4c45-bd26-82773ea350a3Product name220220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690fProduct name420220314
320f244d-8b4e-4893-9f14-104b2a8e0aafProduct name220201007
7ff71f22-5b66-4a3d-bf64-671893a6409dProduct name220201007
6f122144-2ceb-48fa-a906-0d2eb742717eProduct name120190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67Product name120181211
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911
d1784558-3c5f-4d73-8a7c-051102bb6c92Product name120160405
7fd46899-3505-4ed4-b856-6b2509a76004Product name120151123
0583b5e6-2e6e-c94b-9ff6-81a81ba199deProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42385-953-30Emtricitabine and Tenofovir Disoproxil Fumarate30 in 1 BOTTLETABLET, FILM COATED308
42385-953-90Emtricitabine and Tenofovir Disoproxil Fumarate90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42385-953-30EA - Each42385-9537acef56f-0876-4b46-9add-c4da67aeabfe12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42385-953EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [LAURUS LABS LIMITED]7Current NDC, Legacy NDC, 2 package rows20250108_4a7ccbbf-da20-4012-9717-31c411efb3fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSN4a7ccbbf-da20-4012-9717-31c411efb3fb8
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCD4a7ccbbf-da20-4012-9717-31c411efb3fb8
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY4a7ccbbf-da20-4012-9717-31c411efb3fb8
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSNa78b51c9-c944-4b00-af81-9ecbfbb29fd16
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCDa78b51c9-c944-4b00-af81-9ecbfbb29fd16
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYa78b51c9-c944-4b00-af81-9ecbfbb29fd16
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSN7bf86d9d-999a-4b64-849a-0d43bbf7b7664
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCD7bf86d9d-999a-4b64-849a-0d43bbf7b7664
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY7bf86d9d-999a-4b64-849a-0d43bbf7b7664
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSNb8c5f114-61db-4797-b75e-c103d2d1820e2
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSNfc61eee9-ee14-9078-e053-6394a90a22f42
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCDb8c5f114-61db-4797-b75e-c103d2d1820e2
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCDfc61eee9-ee14-9078-e053-6394a90a22f42
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYb8c5f114-61db-4797-b75e-c103d2d1820e2
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYfc61eee9-ee14-9078-e053-6394a90a22f42
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSN4feb83a5-9142-0c67-e063-6394a90a710f1
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCD4feb83a5-9142-0c67-e063-6394a90a710f1
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY4feb83a5-9142-0c67-e063-6394a90a710f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42385-953-304238509533030 TABLET, FILM COATED in 1 BOTTLE (42385-953-30) 2019-07-260000-00-00NoNoCurrent
42385-953-904238509539090 TABLET, FILM COATED in 1 BOTTLE (42385-953-90) 2019-07-260000-00-00NoNoCurrent